[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Proposed Rules]
[Pages 38902-38916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18456]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 862, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884,
886, 888, 890, and 892
[Docket No. 95N-0139]
Medical Devices; Proposed Reclassification and Exemption From
Premarket Notification for Certain Classified Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify 112 generic types of class II devices into class I based on
new information respecting such devices. FDA is also proposing to
exempt the 112 generic types of devices, and 12 already classified
generic types of class I devices, from the requirement of premarket
notification, with limitations. For the devices for which exemptions
are being proposed, FDA has determined that manufacturers' submissions
of premarket notifications are unnecessary for the protection of the
public health and that the agency's review of such submissions will not
advance its public health mission. Granting the exemptions will allow
the agency to make better use of its resources and thus better serve
the public.
DATES: Submit written comments by October 11, 1995. For the devices the
agency is proposing to reclassify into class I and exempt from the
requirement of premarket notification, FDA is proposing that any final
rule that may issue based on this proposed rule become effective August
28, 1995.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Melpomeni K. Jeffries, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2186.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321
et. seq.), as amended by the Medical Devices
[[Page 38903]]
Amendments of 1976 (Pub. L. 94-295, hereinafter called the amendments)
and the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629),
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the act (21 U.S.C. 360c)
establishes three classes of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness: Class I, general controls; class II, special controls;
and class III, premarket approval.
The effect of classifying a device into class I is to require that
the device meet only the general controls which are applicable to all
devices. Two types of devices are classified into class I. The first
type of class I device is comprised of those devices for which general
controls are sufficient to provide reasonable assurance of the safety
and effectiveness of the devices (section 513(a)(1)(A)(i) of the act).
The second type of class I device consists of those devices for which
insufficient information exists to determine that general controls are
sufficient to provide reasonable assurance of the safety and
effectiveness of the device * * * but are not purported or represented
to be for a use in supporting or sustaining human life or for a use
which is of substantial importance in preventing impairment of human
health and do not present a potential unreasonable risk of illness or
injury (section 513(a)(1)(A)(ii) of the act). A ``potential
unreasonable risk of illness or injury'' includes actual risk, as well
as potential risk. Thus, the risk may be one demonstrated by reported
injuries; i.e., medical device reports (MDR's), or it may simply be
foreseeable. See H. Rept. 853, 94th Cong., 2d. sess. 36 (1990).
The effect of classifying a device into class II is to require the
device to meet general controls as well as special controls, which
together provide reasonable assurance of the safety and effectiveness
of the device. Class II devices include devices which cannot be
classified in class I because general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness and for which there is sufficient information to
establish special controls to provide such assurance, including the
promulgation of performance standards (see section 513(a)(1)(B) of the
act).
The effect of classifying a device into class III is to require
each manufacturer of the device to submit to FDA a premarket approval
application (PMA) that includes information concerning safety and
effectiveness of the device.
II. Reclassification Criteria
Pursuant to section 513(e)(1) of the act, based on new information
respecting a device, the agency may, upon its own initiative, by
regulation change a device's classification and revoke, because of the
change in classification, any regulation or requirement in effect with
respect to such device under sections 514 or 515 of the act (21 U.S.C.
360d or 21 U.S.C. 360e). The new information respecting a device must
demonstrate that either more regulatory control is needed to provide
reasonable assurance of the device's safety and effectiveness or that
less regulatory control is sufficient to provide such assurance. The
following developments have produced new information relating to the
devices which justifies reclassifying these devices.
A. The SMDA Provisions
In the Federal Register of September 14, 1984 (49 FR 36326 at
36348), FDA issued MDR regulations (21 CFR part 803). These regulations
required manufacturers and importers of medical devices, including
diagnostic devices, to report to FDA whenever the manufacturer or
importer becomes aware of information that reasonably suggests that one
of its marketed devices: (1) May have caused or contributed to a death
or serious injury, or (2) has malfunctioned and that the device or any
other device marketed by the manufacturer or importer would be likely
to cause or contribute to a death or serious injury if the malfunction
were to recur. Because these MDR regulations were not always adequate
to protect the public health, the SMDA, which was signed into law on
November 28, 1990, added the following MDR requirements and provisions,
as well as other requirements and provisions:
(1) Section 518(e) of the act (21 U.S.C. 360h(e)) allows FDA to
order a manufacturer or other appropriate firm to immediately cease
distribution of a device and immediately notify health professionals
and device user facilities to cease using the device after FDA has
determined that there is a reasonable probability that the device would
cause serious adverse health consequences or death.
(2) Section 519(a)(6) of the act (21 U.S.C. 360i(a)(6)) requires
distributors of medical devices to report to FDA adverse experiences
related to devices, and to submit copies of reports to device
manufacturers.
(3) Section 519(b)(1) of the act (21 U.S.C. 360i(b)(1)) requires
certain device user facilities (hospitals, nursing homes, ambulatory
surgical facilities, and outpatient treatment facilities which are not
physician's offices) to report to FDA and the manufacturer, if known,
deaths related to medical devices. Additionally, under this section,
device user facilities are required to report to the manufacturer, or
to FDA if the manufacturer is unknown, device-related serious illnesses
or injuries. User facilities are also required to submit a semiannual
report to FDA summarizing the reports they have submitted. Under this
section, reporting is limited to events involving a facility's
patients.
(4) Section 519(d) of the act (21 U.S.C. 360e(d)) requires
manufacturers, importers, and distributors to certify to FDA the number
of reports submitted in a year or the fact that no such reports have
been submitted to the agency.
(5) Section 519(f) of the act (21 U.S.C. 360i(f)) requires
manufacturers, importers, and distributors to report to FDA any
removals or corrections of a device intended to reduce a risk to health
posed by a device or to remedy a violation of the act which may present
a risk to health.
These new authorities, which are applicable to all devices,
including class I devices, will enable FDA to monitor the 112 devices
proposed for reclassification more closely and to take appropriate
remedial action, if necessary.
B. The Device Priority Model
Assuring the safety and effectiveness of all medical devices is an
extremely complex and difficult task in light of the number and
diversity of devices being marketed. Thus, in 1989, FDA's Office of
Standards and Regulations established a Device Priority Model (DPM) to
help set priorities for all medical device activities (Ref. 1).
The DPM uses six general parameters, referred to as evaluation
factors, to describe and calculate a priority score for each device.
The six evaluation factors used in the model are: Frequency of
mortality, effectiveness, health benefit, frequency of use, frequency
of serious injury, and frequency of less serious injury.
The values for these evaluation factors are combined linearly using
weights which represent the relative societal importance of each
evaluation factor. The evaluation factors and assigned model weights
are as follows: Frequency of death .38, frequency of serious injury
.30, frequency of less serious injury .12, frequency of use .08, health
benefit .08, and effectiveness .04.
After assigning model weights to the evaluation factors, a three
level scoring scheme is applied. Predetermined
[[Page 38904]]
ranges of the values of the evaluation factors were used to determine a
high, medium, or low scoring level. For frequency of death, frequency
of serious injury, and frequency of less serious injury, the
correspondence between the estimates for evaluation factor values and
evaluation factor scores are: High = 100, medium = 50, and low = 0. The
corresponding evaluation factor values and evaluation factor scores for
the remaining three evaluation factors (frequency of use, health
benefit, and effectiveness) are reversed; low = 100, medium = 50, high
= 0. The reason for this reversal is as follows: If one considers two
devices that are associated with an equal annual incidence of deaths
and injuries, the device that should have the highest priority for FDA
action is the one with the highest intrinsic risk per use, the lowest
health benefit, and the lowest effectiveness.
The resulting number is called the priority score and is calculated
by multiplying the score by the weight. The priority score is used to
flag devices that may require more extensive analysis.
C. The Three Tier System
In early 1994, FDA's Office of Device Evaluation undertook a risk
assessment of all devices in order to ensure the proper allocation of
resources for the review process. Under this risk assessment, all class
I, class II, and class III devices were placed into one of three tiers
based upon the inherent risk associated with each device. Tier 3
devices include many first and second of a kind devices utilizing new
technology or having new intended uses(s), as well as other devices
determined by their inherent risk to require an intensive review. These
tier 3 devices require intensive scientific and labeling review by a
review team as well as advisory panel input. Most tier 3 devices
require the submission of a premarket approval application. Tier 2
devices include devices which require routine scientific and labeling
review. This tier encompasses the majority of 510(k)'s and select
PMA's. Tier 1 devices include devices which require only a focused
labeling review for intended use/indications for use and devices which
have: (1) A score in the DPM less than 30 and/or; (2) no MDR death
reports in any of the previous 3 years; and (3) 10 or fewer total
injury reports in the previous 3 years.
III. Class II Devices To Be Reclassified Into Class I
The agency has carefully reviewed all available information
concerning all class II, tier 1 devices. Based on this review, FDA is
now proposing to reclassify 112 class II, tier 1 devices into class I.
All of these devices were originally classified into class II under the
original definition of class II devices which was defined as ``a device
which cannot be classified as a class I because general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, for which there is sufficient information to
establish a performance standard to provide such assurance, * * *.''
See H. Rept. 94-853, 94th Cong., 2d sess. 107 (1976). To date, no
performance standards have been promulgated. Thus, any risks presented
by these 112 devices have been addressed solely by general controls.
The lack of adverse events or threats to the public health reported in
the new information described above, supports agency's conclusion that
general controls are adequate to provide reasonable assurance of safety
and effectiveness for the 112 devices. In light of the new SMDA
requirements, the new information gathered in response to the
development of the DPM, and the three tier risk assessment system, FDA
has determined that general controls will provide reasonable assurance
of the safety and effectiveness of these devices.
IV. Proposed Exemptions
Section 513(d)(2)(A) of the act authorizes FDA to exempt, by
regulation, a generic type of class I device from, among other things,
the requirement of premarket notification in section 510(k) of the act
(21 U.S.C. 360(k)). Such an exemption permits manufacturers to
introduce into commercial distribution generic types of devices without
first submitting a premarket notification to FDA. When FDA issued
proposed regulations classifying preamendments devices, the agency
focused on granting exemptions from the requirement of premarket
notification principally when the advisory panels included them in
their recommendations to the agency. Subsequently, FDA decided to
exempt certain additional class I devices from the requirement of
premarket notification in order to reduce the number of unnecessary
premarket notifications. Moreover, in accordance with the agency's
policy of reducing the number of unnecessary premarket notifications,
in the Federal Register of December 7, 1994 (59 FR 63005), FDA exempted
148 generic types of class I devices from the requirement of premarket
notification, with limitations. These actions help to free agency
resources for the review of more complex notifications to FDA.
A. Description of Proposed Exemptions
In considering whether to exempt additional class I devices from
premarket notification, FDA focused on whether notification for the
type of device is unnecessary for the protection of the public health.
For the devices in this document, FDA has concluded that premarket
notification is unnecessary primarily for the following reasons:
(1) The device does not have a significant history of false or
misleading claims or of risks associated with inherent characteristics
of the device, such as device design or materials. When making these
determinations, FDA generally has considered the frequency,
persistence, cause, or seriousness of such claims or risks, as well as
other factors deemed relevant.
(2) In general, the following factors apply: (a) Characteristics of
the device necessary for its safe and effective performance are well
established; (b) anticipated changes in the device that could affect
safety and effectiveness will either: (i) Be readily detectable by
users by visual examination or other means, such as routine testing,
before causing harm, e.g., testing of a clinical laboratory reagent
with positive and negative controls; or (ii) not materially increase
the risk of injury, incorrect diagnosis, or ineffective treatment; and
(c) any changes in the device would not be likely to result in a change
in the device's classification.
For the 124 devices, FDA has made the determinations described
above based on its knowledge of the devices, including past experience
and relevant reports or studies on device performance. Where FDA has
concerns only about certain types of changes to a particular class I
device, the agency is proposing a limited exemption from premarket
notification for that generic type of device. A limited exemption will
specify the types of changes to the device for which manufacturers are
required to submit a premarket notification. For example, for some
devices FDA is proposing to exempt the device from the requirement of
premarket notification except when a manufacturer intends to use a
different material.
FDA advises manufacturers that an exemption from the requirement of
premarket notification is not an exemption from any of the other
general controls under the act, including current good manufacturing
practices (CGMP's), unless explicitly stated. Indeed, FDA's decision to
propose 510(k) exemptions for these devices is based, in part, on the
fact that compliance with CGMP's will help ensure product quality.
[[Page 38905]]
FDA's decision to grant an exemption from the requirement of
premarket notification for a generic type of class I device will be
based upon the existing and reasonably foreseeable characteristics of
commercially distributed devices within that generic type. Because FDA
cannot anticipate every change or modification to a device,
manufacturers of any commercially distributed class I device for which
FDA has granted an exemption from the requirement of premarket
notification are still required to submit a premarket notification to
FDA before introducing a device or delivering it for introduction into
commercial distribution when:
(1) The device is intended for a use different from its intended
use before May 28, 1976, or the device is intended for a use different
from the intended use of a preamendments device or a legally marketed
device; e.g., the device is intended for a different medical purpose,
or the device is intended for lay use instead of use by health care
professionals; or
(2) The modified device operates using a different fundamental
scientific technology than used by the device before May 28, 1976;
e.g., a surgical instrument cuts tissue with a laser beam rather than
with a sharpened metal blade, or an in vitro diagnostic device detects
or identifies infectious agents by using a deoxyribonucleic acid (DNA)
probe or nucleic acid hybridization technology rather than culture or
immunoassay technology.
Such changes or modifications to class I devices that are exempt
from premarket notification would mean the exemption would no longer
apply. Changes or modifications to devices that are not exempt from
premarket notification requirements under any regulation must undergo a
more comprehensive assessment to determine the impact of the change or
modification on the device's safety and effectiveness. FDA intends to
develop guidance clarifying when a change or modification to a device
requires submission of a premarket notification as defined in 21 CFR
807.81(a)(3).
On the dates listed in Table I, FDA published final regulations
classifying, among others, the devices listed below. When FDA
classified these devices, the agency did not exempt them from the
requirement of premarket notification. Based on the analysis described
above, FDA has now determined that premarket notification with respect
to the devices listed below is unnecessary for the protection of the
public health and will not advance FDA's public health mission. This
approach is consistent with the recommendation in the May 1993 report
of the Subcommittee on Oversight and Investigations of the Committee on
Energy and Commerce, U.S. House of Representatives, entitled ``Less
Than the Sum of its Parts Reforms Needed in the Organization,
Management, and Resources of The Food and Drug Administration's Center
for Devices and Radiological Health.''
As stated above, earlier this year, the Office of Device Evaluation
undertook a risk assessment of all devices in order to ensure the
proper allocation of resources in the review process. All of the class
II devices listed below were placed in tier 1, the category of devices
which have a minimal inherent risk and whose review focuses upon
intended use. As stated in the Federal Register of July 21, 1994 (59 FR
37378), FDA is now proposing to reclassify 112 class II, tier 1 devices
into class I and exempt these devices, along with 12 class I, tier 1
devices, from the requirement of premarket notification, with
limitations.
FDA is proposing to exempt from the requirement of premarket
notification, with limitations, the 124 generic type of devices
(including 12 already classified generic types of class I devices;
chromatographic separation material for clinical use (Sec. 862.2230 (21
CFR 862.2230)); dental floss (Sec. 872.6390 (21 CFR 872.6390));
acoustic chamber for audiometric testing (Sec. 874.1060 (21 CFR
874.1060)); ear, nose, and throat bur (Sec. 874.4140 (21 CFR
874.4140)); nasopharyngeal catheter (Sec. 874.4175 (21 CFR 874.4175));
otoscope (Sec. 874.4770 (21 CFR 874.4770)); nonpowered breast pump
(Sec. 884.5150 (21 CFR 884.5150)); unscented menstrual pad
(Sec. 884.5435 (21 CFR 884.5435)); cast removal instrument
(Sec. 888.5960 (21 CFR 888.5960)); flotation cushion (Sec. 890.3175 (21
CFR 890.3175)); traction accessory (Sec. 890.5925 (21 CFR 890.5925));
and personnel protective shield (Sec. 892.6500 (21 CFR 892.6500))
listed below:
Table 1
------------------------------------------------------------------------
Number of
devices
CFR part Title proposed
to be
exempt
------------------------------------------------------------------------
862............... Clinical Chemistry and Clinical 1
Toxicology Devices; May 1, 1987 (52 FR
16102).
866............... Immunology and Microbiology Devices; 5
November 8, 1982 (47 FR 50814).
868............... Anesthesiology Devices; July 16, 1982 (47 40
FR 31130).
870............... Cardiovascular Devices; February 5, 1980 10
(45 FR 7904).
872............... Dental Devices; August 12, 1987 (52 FR 4
300820); November 20, 1990 (55 FR
484360).
874............... Ear, Nose, and Throat Devices; November 6
6, 1986 (51 FR 40378).
876............... Gastroenterology-Urology Devices; 11
November 23, 1983 (48 FR 53012); June
12, 1989 (54 FR 25042).
878............... General and Plastic Surgery Devices; June 4
24, 1988 (53 FR 23856).
880............... General Hospital and Personal Use 4
Devices; October 21, 1980 (45 FR 69678).
882............... Neurological Devices; September 4, 1979 2
(44 FR 51726).
884............... Obstetrical and Gynecological Devices; 11
February 26, 1980 (45 FR 12682).
886............... Ophthalmic Devices; September 2, 1987 (52 4
FR 33346); November 20, 1990 (55 FR
48436).
888............... Orthopedic Devices; September 4, 1987 (52 3
FR 33686); November 20, 1990 (55 FR
48436).
890............... Physical Medicine Devices; November 23, 12
1983 (48 FR 53032).
892............... Radiology Devices; January 20, 1988 (53 7
FR 1554).
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Total....... ......................................... 124
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[[Page 38906]]
Table 2.--Clinical Chemistry and Clinical Toxicology Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
862.2230.......... Chromatographic separation material for clinical
use.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of device listed in Table 2 above.
Table 3.--Immunology and Microbiology Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
866.2160.......... Coagulase plasma.
866.3720.......... Streptococcus spp. exoenzyme reagents.
866.5520.......... Immunoglobulin G (Fab fragment specific)
immunological test system.
886.5530.......... Immunoglobulin G (Fc fragment specific)
immunological test system.
866.5860.......... Total spinal fluid immunological test system.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 3 above.
Table 4.--Anesthesiology Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
868.1100.......... Arterial blood sampling kit.
868.1575.......... Gas collection vessel.
868.1870.......... Gas volume calibrator.
868.2300.......... Bourdon gauge flowmeter.
868.2320.......... Uncompensated thorpe tube flowmeter.
868.2340.......... Compensated thorpe tube flowmeter.
868.2350.......... Gas calibration flowmeter.
868.2610.......... Gas pressure gauge.
868.2620.......... Gas pressure calibrator.
868.2700.......... Pressure regulator.
868.2875.......... Differential pressure transducer.
868.2885.......... Gas flow transducer.
868.2900.......... Gas pressure transducer.
868.5100.......... Nasopharyngeal airway.
868.5110.......... Oropharyngeal airway.
868.5240.......... Anesthesia breathing circuit.
868.5300.......... Carbon dioxide absorbent.
868.5310.......... Carbon dioxide absorber.
868.5320.......... Reservoir bag.
868.5375.......... Heat and moisture condenser (artificial nose).
868.5460.......... Therapeutic humidifier for home use.
868.5530.......... Flexible laryngoscope.
868.5540.......... Rigid laryngoscope.
868.5550.......... Anesthetic gas mask.
868.5570.......... Nonrebreathing mask.
868.5580.......... Oxygen mask.
868.5590.......... Scavenging mask.
868.5600.......... Venturi mask.
868.5770.......... Tracheal tube fixation device.
868.5780.......... Tube introduction forceps.
868.5790.......... Tracheal tube stylet.
868.5810.......... Airway connector.
868.5820.......... Dental protector.
868.5860.......... Pressure tubing and accessories.
868.5975.......... Ventilator tubing.
868.5995.......... Tee drain (water trap).
868.6400.......... Calibration gas.
868.6820.......... Patient position support.
868.6885.......... Medical gas yoke assembly.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 4 above.
Table 5.--Cardiovascular Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
870.2390.......... Phonocardiograph.
870.2600.......... Signal isolation system.
870.2620.......... Line isolation monitor.
870.2640.......... Portable leakage current alarm.
870.2810.......... Paper chart recorder.
870.3650.......... Pacemaker polymeric mesh bag.
870.3670.......... Pacemaker charger.
870.3690.......... Pacemaker test magnet.
870.3935.......... Prosthetic heart valve holder.
870.3945.......... Prosthetic heart valve sizer.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 5 above.
Table 6.--Dental Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
872.1840.......... Dental x-ray position indicating device.
872.1850.......... Lead-lined position indicator.
872.4630.......... Dental operating light.
872.6390.......... Dental floss.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices in Table 6 listed above.
The proposed exemption for dental floss (Sec. 872.6390 (21 CFR
872.6390)) is limited and would apply only when the device is composed
of inert material and is not coated or impregnated with chemicals
intended to provide a therapeutic benefit or interact with tissues of
the oral cavity.
Table 7.--Ear, Nose, and Throat Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
874.1060.......... Acoustic chamber for audiometric testing.
874.1080.......... Audiometer calibration set.
874.4140.......... Ear, nose, and throat bur.
874.4175.......... Nasopharyngeal catheter.
874.4350.......... Ear, nose, and throat fiberoptic light source and
carrier.
874.4770.......... Otoscope.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 7 above.
The proposed exemption for the otoscope (Sec. 874.4770 (21 CFR
874.4770)) is limited and would apply only when used in the external
ear canal.
Table 8.--Gastroenterology-Urology Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
876.1075.......... Gastroenterology-urology biopsy instrument.
876.1400.......... Stomach pH electrode.
876.1500.......... Endoscope and accessories.
876.1800.......... Urine flow or volume measuring system.
876.4590.......... Interlocking urethral sound.
876.4890.......... Urological catheter and accessories.
876.5090.......... Suprapublic urological catheter and accessories.
876.5130.......... Urological catheter and accessories.
876.5450.......... Rectal dilator.
876.5520.......... Urethral dilator.
876.5540.......... Blood access device and accessories.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 8 above.
The proposed exemption for the gastroenterology- urology biopsy
instrument (Sec. 876.1075 (21 CFR 876.1075)) is limited and would apply
only to the biopsy forceps cover and the nonelectric biopsy forceps.
The proposed exemption for the endoscope and accessories (Sec. 876.1500
(21 CFR 876.1500)) is limited and would apply only to the following
specified devices: Photographic accessories for endoscope,
miscellaneous bulb adapter for endoscope, binocular attachment for
endoscope, eyepiece attachment for
[[Page 38907]]
prescription lens, teaching attachment, inflation bulb, measuring
device for panendoscope, photographic equipment for physiologic
function monitor, special lens instrument for endoscope, smoke removal
tube, rechargeable battery box, pocket battery box, bite block for
endoscope, and cleaning brush for endoscope. The proposed exemption for
the urine flow or volume measuring system (Sec. 876.1800 (21 CFR
876.1800)) is limited and would apply only to the disposable,
nonelectrical urine flow rate measuring device and the nonelectrical
urinometer. The proposed exemption for the electrically powered
urological table and accessories (Sec. 876.4890 (21 CFR 876.4890)) is
limited and would apply only to stirrups. The proposed exemption for
the suprapubic urological catheter and accessories (Sec. 876.5090 (21
CFR 876.5090)) is limited and would apply only to the catheter punch
instrument, nondisposable cannula and trocar, and gastro-urological
trocar. The proposed exemption for the urological catheters and
accessories (Sec. 876.5130 (21 CFR 876.5130)) is limited and would
apply only to the ureteral stylet (guidewire), stylet for gastro-
urological catheter, ureteral catheter holder, ureteral catheter
adapter, and ureteral catheter connector. The proposed exemption for
the urethral dilator (Sec. 876.5520 (21 CFR 876.5520)) is limited and
would apply only to the urethrometer, urological bougie, filiform and
filiform follower, and metal or plastic urethral sound. Finally, the
proposed exemption for the blood access device and accessories
(Sec. 876.5540 (21 CFR 876.5540)) is limited and would apply only to
the following accessories for both the implanted and the nonimplanted
blood access device: Cannula clamp, disconnect forceps, crimp plier,
tub plier, crimp ring, and joint ring.
Table 9.--General and Plastic Surgery Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
878.4450.......... Nonabsorbable gauze for internal use.
878.4810.......... Laser surgical instrument for use in general and
plastic surgery and in dermatology.
878.5350.......... Needle-type epilator.
878.5910.......... Pneumatic tourniquet.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for the devices listed in Table 9 above. The
proposed exemption for the laser surgical instrument for use in general
and plastic surgery and in dermatology (Sec. 878.4810 (21 CFR 878.4810)
is limited and would apply only to gas mixtures used as the lasing
medium for this class of lasers.
Table 10.--General Hospital and Personal Use Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
880.2720.......... Patient scale.
880.2900.......... Clinical color change thermometer.
880.6320.......... AC-powered medical examination light.
880.5560.......... Temperature regulated water mattress.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 10
above.
Table 11.--Neurological Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
882.1410.......... Electroencephalograph electrode/lead tester.
882.4325.......... Cranial drill handpiece (brace).
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 11
above.
Table 12.--Obstetrical and Gynecological Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
884.1550.......... Amniotic fluid sampler (amniocentesis tray).
884.1640.......... Culdoscope and accessories.
884.1690.......... Hysteroscope and accessories.
884.1700.......... Hysteroscopic insufflator.
884.1720.......... Gynecologic laparoscope and accessories.
884.1730.......... Laparoscopic insufflator.
884.4530.......... Obstetric-gynecological specialized manual
instrument.
884.5150.......... Nonpowered breast pump.
884.5425.......... Scented or scented deodorized menstrual pad.
884.5435.......... Unscented menstrual pad.
884.5900.......... Therapeutic vaginal douche apparatus.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 12
above. The proposed exemption for the culdoscope and accessories
(Sec. 884.1640 (21 CFR 884.1640)) and the laparoscope and accessories
(Sec. 884.1720 (21 CFR 884.1720)) are limited and would apply only to
culdoscope and laparoscope accessories, respectively, that are not part
of a specialized instrument or device delivery system and which do not
have adapters, connectors, channels, or do not have portals for
electrosurgical, laser, or other power sources. Such culdoscope and
laparoscope accessory instruments are limited to: Lens cleaning brush;
biopsy brush; clip applier (without clips); applicator; cannula
(without trocar or valves); ligature carrier/needle holder; clamp/
hemostat/grasper; curette; instrument guide; ligature passing and
knotting instrument; suture needle (without suture); retractor,
mechanical (noninflatable); snare; stylet; forceps; dissector,
mechanical (noninflatable); scissors; and suction/irrigation probe. The
proposed exemption for the gynecological hysteroscope and accessories
(Sec. 884.1690 (21 CFR 884.1690)) is limited and would apply only to
the following manual accessories: Lens cleaning brush; cannula (without
trocar or valves); clamp/hemostat/grasper; curette; instrument guide;
forceps; dissector; mechanical (noninflatable); and scissors. The
proposed exemption for the hysteroscopic or laparoscopic insufflator
accessories (Secs. 884.1700 and 884.1730 (21 CFR 884.1700 and
884.1730), respectively) is limited and would apply only to tubing and
tubing/filter kits used for hysteroscopic or laparoscopic insufflation
as single use tubing kits used for only one clinical purpose, i.e.,
pneumoperitoneum or intrauterine insufflation, but not both. The
proposed exemption does not apply to accessories such as hysteroscopic
introducer sheaths or Verres needles. The proposed exemption for the
obstetric-gynecological specialized manual instruments (Sec. 884.4530
(21 CFR 884.4530)) is limited and would apply only to the following
devices: Amniotome; uterine curette; cervical dilator (fixed-size
bougies); cerclage needle; intrauterine device remover; uterine sound;
and gynecological biopsy forceps. The proposed exemption for the
nonpowered breast pump (Sec. 884.5150) is limited and would apply only
if the device is using either a bulb or telescoping mechanism which
does not develop more than 250 mm Hg suction, and the device materials
that contact breast or breast milk do not produce cytotoxicity,
irritation, or sensitization effects. The proposed exemption for the
scented or scented deodorized menstrual pad (Sec. 884.5425 (21 CFR
884.5425)) and the unscented menstrual pad (Sec. 884.5435) is limited
and would
[[Page 38908]]
apply only if the menstrual pad is made from cotton or rayon and the
body contact material(s) are safety tested for dermal irritation,
dermal sensitivity, acute toxicity, and mucosal irritation. Finally,
the proposed exemption for the therapeutic vaginal douche apparatus
(Sec. 884.5900 (21 CFR 884.5900)) is limited and would apply only to
devices which operate by gravity feed.
Table 13.--Ophthalmic Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
886.1405.......... Ophthalmic trial lens set.
886.1750.......... Skiascopic rack.
886.1760.......... Ophthalmic refractometer.
886.3200.......... Artificial eye.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 13
above. The proposed exemption for the artificial eye (Sec. 886.3200 (21
CFR 886.3200)) is limited and would apply only to devices made of the
same materials, have the same chemical composition, and use the same
manufacturing and disinfection processes as currently legally marketed
devices.
Table 14.--Orthopedic Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
888.1100.......... Arthroscope.
888.3000.......... Bone cap.
888.5960.......... Cast removal instrument.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 14
above. The proposed exemption for the arthroscope (Sec. 888.1100 (21
CFR 888.1100)) is limited and would apply only to the following manual
arthroscope instruments: Cannulas, curettes, drill guides, forceps,
gouges, graspers, knives, obturators, osteotomes, probes, punches,
rasps, retractors, rongeurs, suture passers, suture knot pushers,
suture punches, switching rods, and trocars.
Table 15.--Physical Medicine Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
890.1575.......... Force-measuring platform.
890.1600.......... Intermittent pressure measurement system.
890.1615.......... Miniature pressure transducer.
890.3175.......... Flotation cushion.
890.3760.......... Powered table.
890.5380.......... Powered exercise equipment.
890.5410.......... Powered finger exerciser.
890.5660.......... Therapeutic massager.
890.5925.......... Traction accessory.
890.5940.......... Chilling unit.
890.5950.......... Powered heating unit.
890.5975.......... Therapeutic vibrator.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 15
above.
Table 16.--Radiology Devices
------------------------------------------------------------------------
CFR section Device
------------------------------------------------------------------------
892.1700.... Diagnostic x-ray high voltage generator.
892.1760.... Diagnostic x-ray housing assembly.
892.1770.... Diagnostic x-ray tube mount.
892.1830.... Radiologic patient cradle.
892.1880.... Wall-mounted radiographic cassette holder.
892.5780.... Light beam patient position indicator.
892.6500.... Personnel protective shield.
------------------------------------------------------------------------
FDA is proposing to grant an exemption from the requirement of
premarket notification for each of the devices listed in Table 16
above. The proposed exemption for the personnel protective shield
(Sec. 892.6500 (21 CFR 892.6500)) is limited and would only apply to
devices whose labeling specifies the lead equivalence.
V. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. The Device Priority Model: Development and Applications,
Office of Standards and Regulations, FDA, Rockville, MD, October
1989.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment or an environmental impact statement is
required.
VII. Analysis of Impacts
FDA has examined the impact of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a
proposal on small entities. Because this proposal would reduce a
regulatory burden by exempting manufacturers of devices subject to the
rule from the requirements or premarket notification, the agency
certifies that the proposed rule will not have a significant economic
impact on a substantial number of small entities. Therefore, under the
Regulatory Flexibility Act, no further analysis is required.
VIII. Request for Comments
Interested persons may, on or before October 11, 1995, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and
890
Medical devices.
21 CFR Part 866
Biologics, Laboratories, Medical devices.
21 CFR Part 886
Medical devices, Ophthalmic goods and services.
[[Page 38909]]
21 CFR Part 892
Medical devices, Radiation protection, X-rays.
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
1. The authority citation for 21 CFR part 862 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 862.2230 is amended by revising paragraph (b) to read as
follows:
Sec. 862.2230 Chromatographic separation material for clinical use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
3. The authority citation for 21 CFR part 866 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
4. Section 866.2160 is amended by revising paragraph (b) to read as
follows:
Sec. 866.2160 Coagulase plasma.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
5. Section 866.3720 is amended by revising paragraph (b) to read as
follows:
Sec. 866.3720 Streptococcus spp. exoenzyme reagents.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
6. Section 866.5520 is amended by revising paragraph (b) to read as
follows:
Sec. 866.5520 Immnunoglobulin G (Fab fragment specific) immunological
test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
7. Section 866.5530 is amended by revising paragraph (b) to read as
follows:
Sec. 866.5530 Immunoglobulin G (Fc fragment specific) immunological
test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
8. Section 866.5860 is amended by revising paragraph (b) to read as
follows:
Sec. 866.5860 Total spinal fluid immunological test system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 868--ANESTHESIOLOGY DEVICES
9. The authority citation for 21 CFR part 868 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
10. Section 868.1100 is amended by revising paragraph (b) to read
as follows:
Sec. 868.1100 Arterial blood sampling kit.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
11. Section 868.1575 is amended by revising paragraph (b) to read
as follows:
Sec. 868.1575 Gas collection vessel.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
12. Section 868.1870 is amended by revising paragraph (b) to read
as follows:
Sec. 868.1870 Gas volume calibrator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
13. Section 868.1975 is amended by revising paragraph (b) to read
as follows:
Sec. 868.1975 Water vapor analyzer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
14. Section 868.2300 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2300 Bourdon gauge flowmeter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
15. Section 868.2320 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2320 Uncompensated thorpe tube flowmeter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
16. Section 868.2340 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2340 Compensated thorpe tube flowmeter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
17. Section 868.2350 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2350 Gas calibration flowmeter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
18. Section 868.2610 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2610 Gas pressure gauge.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
19. Section 868.2620 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2620 Gas pressure calibrator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
20. Section 868.2700 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2700 Pressure regulator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
21. Section 868.2875 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2875 Differential pressure transducer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
22. Section 868.2885 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2885 Gas flow transducer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket
[[Page 38910]]
notification procedures in subpart E of part 807 of this chapter.
23. Section 868.2900 is amended by revising paragraph (b) to read
as follows:
Sec. 868.2900 Gas pressure transducer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
24. Section 868.5100 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5100 Nasopharyngeal airway.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
25. Section 868.5110 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5110 Oropharyngeal airway.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
26. Section 868.5240 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5240 Anesthesia breathing circuit.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
27. Section 868.5300 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5300 Carbon dioxide absorbent.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
28. Section 868.5310 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5310 Carbon dioxide absorber.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
29. Section 868.5320 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5320 Reservoir bag.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
30. Section 868.5375 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5375 Heat and moisture condenser (artificial nose).
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
31. Section 868.5460 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5460 Therapeutic humidifier for home use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
32. Section 868.5530 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5530 Flexible laryngoscope.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
33. Section 868.5540 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5540 Rigid laryngoscope.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
34. Section 868.5550 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5550 Anesthetic gas mask.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
35. Section 868.5570 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5570 Nonrebreathing mask.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
36. Section 868.5580 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5580 Oxygen mask.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
37. Section 868.5590 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5590 Scavenging mask.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
38. Section 868.5600 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5600 Venturi mask.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
39. Section 868.5770 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5770 Tracheal tube fixation device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
40. Section 868.5780 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5780 Tube introduction forceps.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
41. Section 868.5790 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5790 Tracheal tube stylet.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
42. Section 868.5810 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5810 Airway connector.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
43. Section 868.5820 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5820 Dental protector.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
44. Section 868.5860 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5860 Pressure tubing and accessories.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
45. Section 868.5975 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5975 Ventilator tubing.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
[[Page 38911]]
46. Section 868.5995 is amended by revising paragraph (b) to read
as follows:
Sec. 868.5995 Tee drain (water trap).
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
47. Section 868.6400 is amended by revising paragraph (b) to read
as follows:
Sec. 868.6400 Calibration gas.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
48. Section 868.6820 is amended by revising paragraph (b) to read
as follows:
Sec. 868.6820 Patient position support.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
49. Section 868.6885 is amended by revising paragraph (b) to read
as follows:
Sec. 868.6885 Medical gas yoke assembly.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 870--CARDIOVASCULAR DEVICES
50. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
51. Section 870.2390 is amended by revising paragraph (b) to read
as follows:
Sec. 870.2390 Phonocardiograph.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
52. Section 870.2600 is amended by revising paragraph (b) to read
as follows:
Sec. 870.2600 Signal isolation system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
53. Section 870.2620 is amended by revising paragraph (b) to read
as follows:
Sec. 870.2620 Line isolation monitor.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
54. Section 870.2640 is amended by revising paragraph (b) to read
as follows:
Sec. 870.2640 Portable leakage current alarm.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
55. Section 870.2810 is amended by revising paragraph (b) to read
as follows:
Sec. 870.2810 Paper chart recorder.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
56. Section 870.3650 is amended by revising paragraph (b) to read
as follows:
Sec. 870.3650 Pacemaker polymeric mesh bag.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
57. Section 870.3670 is amended by revising paragraph (b) to read
as follows:
Sec. 870.3670 Pacemaker charger.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
58. Section 870.3690 is amended by revising paragraph (b) to read
as follows:
Sec. 870.3690 Pacemaker test magnet.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
59. Section 870.3935 is amended by revising paragraph (b) to read
as follows:
Sec. 870.3935 Prosthetic heart valve holder.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
60. Section 870.3945 is amended by revising paragraph (b) to read
as follows:
Sec. 870.3945 Prosthetic heart valve sizer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 872--DENTAL DEVICES
61. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
62. Section 872.1840 is amended by revising paragraph (b) to read
as follows:
Sec. 872.1840 Dental x-ray position indicating device.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
63. Section 872.1850 is amended by revising paragraph (b) to read
as follows:
Sec. 872.1850 Lead-lined position indicator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
64. Section 872.4630 is amended by revising paragraph (b) to read
as follows:
Sec. 872.4630 Dental operating light.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
65. Section 872.6390 is amended by revising paragraph (b) to read
as follows:
Sec. 872.6390 Dental floss.
* * * * *
(b) Classification. Class I. If the device is made of inert
materials and is not coated or impregnated with chemicals intended to
provide a therapeutic benefit or interact with tissues of the oral
cavity, it is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter.
PART 874--EAR, NOSE, AND THROAT DEVICES
66. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
67. Section 874.1060 is amended by revising paragraph (b) to read
as follows:
Sec. 874.1060 Acoustic chamber for audiometric testing.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
68. Section 874.1080 is amended by revising paragraph (b) to read
as follows:
Sec. 874.1080 Audiometer calibration test.
* * * * *
[[Page 38912]]
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
69. Section 874.4140 is amended by revising paragraph (b) to read
as follows:
Sec. 874.4140 Ear, nose, and throat bur.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
70. Section 874.4175 is amended by revising paragraph (b) to read
as follows:
Sec. 874.4175 Nasopharyngeal catheter.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
71. Section 874.4350 is amended by revising paragraph (b) to read
as follows:
Sec. 874.4350 Ear, nose, and throat fiberoptic light source and
carrier.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
72. Section 874.4770 is amended by revising paragraph (b) to read
as follows:
Sec. 874.4770 Otoscope.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter only when used in the external ear canal.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
73. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
74. Section 876.1075 is amended by revising paragraph (b) to read
as follows:
Sec. 876.1075 Gastroenterology-urology biopsy instrument.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the biopsy forceps cover and the nonelectric biopsy
forceps. The devices subject to this paragraph (b)(2) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
75. Section 876.1400 is amended by revising paragraph (b) to read
as follows:
Sec. 876.1400 Stomach pH electrode.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
76. Section 876.1500 is amended by revising paragraph (b) to read
as follows:
Sec. 876.1500 Endoscope and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the photographic accessories for endoscope,
miscellaneous bulb adapter for endoscope, binocular attachment for
endoscope, eyepiece attachment for prescription lens, teaching
attachment, inflation bulb, measuring device for panendoscope,
photographic equipment for physiologic function monitor, special lens
instrument for endoscope, smoke removal tube, rechargeable battery box,
pocket battery box, bite block for endoscope, and cleaning brush for
endoscope. The devices subject to this paragraph (b)(2) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
77. Section 876.1800 is amended by revising paragraph (b) to read
as follows:
Sec. 876.1800 Urine flow or volume measuring system.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the disposable, nonelectrical urine flow rate
measuring device, and nonelectrical urinometer. The devices subject to
this paragraph (b)(2) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
78. Section 876.4590 is amended by revising paragraph (b) to read
as follows:
Sec. 876.4590 Interlocking urethral sound.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
79. Section 876.4890 is amended by revising paragraph (b) to read
as follows:
Sec. 876.4890 Urological table and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards) for the
electrically powered urological table and accessories.
(2) Class I for the manually powered table and accessories, and for
stirrups for electrically powered table. The devices subject to this
paragraph (b)(2) are exempt from the premarket notification procedures
in subpart E of part 807 of this chapter.
80. Section 876.5090 is amended by revising paragraph (b) to read
as follows:
Sec. 876.5090 Suprapubic urological catheter and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the catheter punch instrument, nondisposable
cannula and trocar, and gastro-urological trocar. The devices subject
to this paragraph (b)(2) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
81. Section 876.5130 is amended by revising paragraph (b) to read
as follows:
Sec. 876.5130 Urological catheter and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the ureteral stylet (guidewire), stylet for gastro-
urological catheter, ureteral catheter adapter, ureteral catheter
connector, and ureteral catheter holder. The devices subject to this
paragraph (b)(2) are exempt from the premarket notification procedures
in subpart E of part 807 of this chapter.
82. Section 876.5450 is amended by revising paragraph (b) to read
as follows:
Sec. 876.5450 Rectal dilator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
83. Section 876.5520 is amended by revising paragraph (b) to read
as follows:
Sec. 876.5520 Urethral dilator.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the urethrometer, urological bougie, filiform and
filiform follower, and metal or plastic urethral sound. The devices
subject to this paragraph (b)(2) are exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
84. Section 876.5540 is amended by revising paragraph (b)(3) and by
adding new paragraph (b)(4) to read as follows:
Sec. 876.5540 Blood access device and accessories.
* * * * *
(b) * * *
(3) Class II (performance standards) for accessories for both the
implanted and the nonimplanted blood access devices not listed in
paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier,
tube plier, crimp ring, and joint ring,
[[Page 38913]]
accessories for both the implanted and nonimplanted blood access
device. The devices subject to this paragraph (b)(4) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
* * * * *
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
85. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,
360e, 360j, 360l, 371).
86. Section 878.4450 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4450 Nonabsorbable gauze for internal use.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
87. Section 878.4810 is amended by revising paragraph (b) to read
as follows:
Sec. 878.4810 Laser surgical instrument for use in general and plastic
surgery and in dermatology.
* * * * *
(b) Classification. (1) Class II.
(2) Class I for special laser gas mixtures used as a lasing medium
for this class of lasers. The devices subject to this paragraph (b)(2)
are exempt from the premarket notification procedures in subpart E of
part 807 of this chapter.
88. Section 878.5350 is amended by revising paragraph (b) to read
as follows:
Sec. 878.5350 Needle-type epilator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
89. Section 878.5910 is amended by revising paragraph (b) to read
as follows:
Sec. 878.5910 Pneumatic tourniquet.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
90. The authority citation for 21 CFR 880 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
91. Section 880.2720 is amended by revising paragraph (b) to read
as follows:
Sec. 880.2720 Patient scale.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
92. Section 880.2900 is amended by revising paragraph (b) to read
as follows:
Sec. 880.2900 Clinical color change thermometer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
93. Section 880.5560 is amended by revising paragraph (b) to read
as follows:
Sec. 880.5560 Temperature regulated water mattress.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
94. Section 880.6320 is amended by revising paragraph (b) to read
as follows:
Sec. 880.6320 AC-powered medical examination light.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 882--NEUROLOGICAL DEVICES
95. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
96. Section 882.1410 is amended by revising paragraph (b) to read
as follows:
Sec. 882.1410 Electroencephalograph electrode/lead tester.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
97. Section 882.4325 is amended by revising paragraph (b) to read
as follows:
Sec. 882.4325 Cranial drill handpiece (brace).
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
98. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
99. Section 884.1550 is revised to read as follows:
Sec. 884.1550 Amniotic fluid sampler (amniocentesis tray.
(a) Identification. The amniotic fluid sampler (amniocentesis tray)
is a collection of devices used to aspirate amniotic fluid from the
amniotic sac via a transabdominal approach. Components of the
amniocenteses tray include a disposable 3 inch 20 gauge needle with
stylet and a 30 cc. syringe, as well as the various sample collection
accessories, such as vials, specimen containers, medium, drapes, etc.
The device is used at 16-18 weeks gestation for antepartum diagnosis of
certain congenital abnormalities or anytime after 24 weeks gestation
when used to assess fetal maturity.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
100. Section 884.1640 is amended by revising paragraph (b) to read
as follows:
Sec. 884.1640 Culdoscope and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for culdoscope accessories that are not part of a
specialized instrument or device delivery system; do not have adapters,
connectors, channels, or do not have portals for electrosurgical,
laser, or other power sources. Such culdoscope accessory instruments
include: Lens cleaning brush, biopsy brush, clip applier (without
clips), applicator, cannula (without trocar or valves), ligature
carrier/needle holder, clamp/hemostat/grasper, curette, instrument
guide, ligature passing and knotting instrument, suture needle (without
suture), retractor, mechanical (noninflatable), snare, stylet, forceps,
dissector, mechanical (noninflatable) scissors, and suction/irrigation
probe. The devices subject to this paragraph (b)(2) are exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
101. Section 884.1690 is amended by revising paragraph (b) to read
as follows:
Sec. 884.1690 Hysteroscope and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for hysteroscope accessories that are not part of a
specialized instrument or device
[[Page 38914]]
delivery system, do not have adapters, connectors, channels, or do not
have portals for electrosurgical, laser, or other power sources. Such
hysteroscope accessory instruments include: Lens cleaning brush,
cannula (without trocar or valves), clamp/hemostat/grasper, curette,
instrument guide, forceps, dissector, mechanical (noninflatable), and
scissors. The devices subject to this paragraph (b)(2) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
102. Section 884.1700 is amended by revising paragraph (b) to read
as follows:
Sec. 884.1700 Hysteroscopic insufflator.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for tubing and tubing/filter fits which only include
accessory instruments which are not used to effect intrauterine access,
e.g., hysteroscopic introducer sheaths, etc., and single-use tubing
kits used for only intrauterine insufflation. The devices subject to
this paragraph (b)(2) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
103. Section 884.1720 is amended by revising paragraph (b) to read
as follows:
Sec. 884.1720 Gynecologic laparoscope and accessories.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for gynecologic laparoscope accessories that are not
part of a specialized instrument or device delivery system, do not have
adapters, connector channels, or do not have portals for
electrosurgical, lasers, or other power sources. Such gynecologic
laparoscope accessory instruments include: The lens cleaning brush,
biopsy brush, clip applier (without clips), applicator, cannula
(without trocar or valves), ligature carrier/needle holder, clamp/
hemostat/grasper, curette, instrument guide, ligature passing and
knotting instrument, suture needle (without suture), retractor,
mechanical (noninflatable), snare, stylet, forceps, dissector,
mechanical (noninflatable), scissors, and suction/irrigation probe. The
devices subject to this paragraph (b)(2) are exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
104. Section 884.1730 is amended by revising paragraph (b) to read
as follows:
Sec. 884.1730 Laparoscopic insufflator.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for tubing and tubing/filter kits which include
accessory instruments which are not used to effect intra-abdominal
access, Verres needles etc., and single-use tubing kits used for only
intra-abdominal insufflation (pneumoperitoneum). The devices subject to
this paragraph (b)(2) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
105. Section 884.4530 is amended by revising paragraph (b) to read
as follows:
Sec. 884.4530 Obstetric-gynecological specialized manual instrument.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the amniotome, uterine curette, cervical dilator
(fixed-size bougies), cerclage needle, IUD remover, uterine sound, and
gynecological biopsy forceps. The devices subject to this paragraph
(b)(2) are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter.
106. Section 884.5150 is amended by revising paragraph (b) to read
as follows:
Sec. 884.5150 Nonpowered breast pump.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter if the device is using either a bulb or telescoping mechanism
which does not develop more than 250 mm Hg suction, and the device
materials that contact breast or breast milk do not produce
cytotoxicity, irritation, or sensitization effects.
107. Section 884.5425 is amended by revising paragraph (b) to read
as follows:
Sec. 884.5425 Scented or scented deodorized menstrual pad.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for menstrual pads made from cotton or rayon and for
which the body contact material(s) and extracts from the absorbent
material(s) are safety tested for dermal irritation, dermal
sensitivity, acute toxicity, and mucosal irritation. The devices
subject to this paragraph (b)(2) are exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
108. Section 884.5435 is amended by revising paragraph (b) to read
as follows:
Sec. 884.5435 Unscented menstrual pad.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter only when the device is made from cotton or rayon
and for which the body contact material(s) and extracts from the
absorbent material(s) are safety tested for dermal irritation, dermal
sensitivity, acute toxicity, and mucosal irritation.
109. Section 884.5900 is amended by revising paragraph (b) to read
as follows:
Sec. 884.5900 Therapeutic vaginal douche apparatus.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I if the device is operated by gravity feed. Devices
subject to this paragraph (b)(2) are exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
PART 886--OPHTHALMIC DEVICES
110. The authority citation for 21 CFR 886 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
111. Section 886.1405 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1405 Ophthalmic trial lens set.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
112. Section 886.1750 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1750 Skiascopic rack.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
113. Section 886.1760 is amended by revising paragraph (b) to read
as follows:
Sec. 886.1760 Ophthalmic refractometer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
114. Section 886.3200 is revised to read as follows:
Sec. 886.3200 Artificial eye.
(a) Identification. An artificial eye is a device resembling the
anterior portion of the eye, usually made of glass or plastic, intended
to be inserted in a patient's eye socket anterior to an orbital
implant, or the eviscerated eyeball, for cosmetic purposes. The device
is not intended to be implanted.
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter if the device is made from the same materials, has the same
chemical composition, and uses
[[Page 38915]]
the same manufacturing processes as currently legally marketed devices.
PART 888--ORTHOPEDIC DEVICES
115. The authority citation for 21 CFR part 888 continues to read
as follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
116. Section 888.1100 is amended by revising paragraph (b) to read
as follows:
Sec. 888.1100 Arthroscope.
* * * * *
(b) Classification. (1) Class II (performance standards).
(2) Class I for the following manual arthroscopic instruments:
Cannulas, currettes, drill guides, forceps, gouges, graspers, knives,
obturators, osteotomes, probes, punches, rasps, retractors, rongeurs,
suture passers, suture knotpushers, suture punches, switching rods, and
trocars. The devices subject to this paragraph (b)(2) are exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
117. Section 888.3000 is amended by revising paragraph (b) to read
as follows:
Sec. 888.3000 Bone cap.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
118. Section 888.5960 is amended by revising paragraph (b) to read
as follows:
Sec. 888.5960 Cast removal instrument.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 890--PHYSICAL MEDICINE DEVICES
119. The authority citation for 21 CFR part 890 continues to read
as follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
120. Section 890.1575 is amended by revising paragraph (b) to read
as follows:
Sec. 890.1575 Force-measuring platform.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
121. Section 890.1600 is amended by revising paragraph (b) to read
as follows:
Sec. 890.1600 Intermittent pressure measurement system.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
122. Section 890.1615 is amended by revising paragraph (b) to read
as follows:
Sec. 890.1615 Miniature pressure transducer.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
123. Section 890.3175 is amended by revising paragraph (b) to read
as follows:
Sec. 890.3175 Flotation cushion.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
124. Section 890.3760 is amended by revising paragraph (b) to read
as follows:
Sec. 890.3760 Powered table.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
125. Section 890.5380 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5380 Powered exercise equipment.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
126. Section 890.5410 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5410 Powered finger exerciser.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
127. Section 890.5660 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5660 Therapeutic massager.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
128. Section 890.5925 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5925 Traction accessory.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter. The device is also exempt from the current good manufacturing
practice regulations in part 820, with the exception of Sec. 820.180,
with respect to general requirements concerning records, and
Sec. 820.198, with respect to complaint files.
129. Section 890.5940 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5940 Chilling unit.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
130. Section 890.5950 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5950 Powered heating unit.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
131. Section 890.5975 is amended by revising paragraph (b) to read
as follows:
Sec. 890.5975 Therapeutic vibrator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
PART 892--RADIOLOGY DEVICES
132. The authority citation for 21 CFR part 892 continues to read
as follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
133. Section 892.1700 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1700 Diagnostic x-ray high voltage generator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
134. Section 892.1760 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1760 Diagnostic x-ray tube housing assembly.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
135. Section 892.1770 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1770 Diagnostic x-ray tube mount.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket
[[Page 38916]]
notification procedures in subpart E of part 807 of this chapter.
136. Section 892.1830 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1830 Radiologic patient cradle.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
137. Section 892.1880 is amended by revising paragraph (b) to read
as follows:
Sec. 892.1880 Wall mounted radiographic cassette holder.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
138. Section 892.5780 is amended by revising paragraph (b) to read
as follows:
Sec. 892.5780 Light beam patient position indicator.
* * * * *
(b) Classification. Class I. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter.
139. Section 892.6500 is amended by revising paragraph (b) to read
as follows:
Sec. 892.6500 Personnel protective shield.
* * * * *
(b) Classification. Class I. If the device's labeling specifies the
lead equivalence, it is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter.
Dated: July 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18456 Filed 7-27-95; 8:45 am]
BILLING CODE 4160-01-P
